Empowering clinical trials

...to make the impossible possible.

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Moving trials forward. On time. By experience.

As a full-service clinical trial company, we coordinate studies from the first idea until the final results. Our holistic approach is effectively enhanced by our digitally supported procedures. This results in significant advantages arising through synergies between our experts, our partners, physicians and patients.

Clinical Operation

Cross-functional management of all stakeholders during study conduct

Regulatory

Establishing regulatory affairs strategies for clinical research

Medical Writing

Medical expertise creating scientific content in all study phases

Data Management

Risk management by ensuring the highest level of data quality

Pharmacovigilance

Permanent surveillance of patient safety

Biometrics

Understanding data with advanced analytics and innovative methods

Monitoring

Global network of CRAs for on-site and remote monitoring

White Paper

The Three Most Common Challenges in Clinical Trials and Their Solutions

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Learn about the Alcedis Journey

Early Study Planning

It all starts with a vision, a hypothesis, an objective - The foundation for a successful study is laid when experts from all disciplines and departments at Alcedis unite for study planning.

  • In depth analysis, feasibility and market evaluation
  • Sample size calculation and study design
  • Creation of first-step documents like study designs, synopsis or research grant applications
  • Writing of study protocols, observational plans and other required documents (ICF etc.)
  • Choosing appropriate study procedures
  • Study course forecasting and reliable budget plans

Initial Phase

Within the initial phase, we take responsibility for the preparation of all set-up activities on time. This contains regulatory requirements, study materials, site preparation and implementing the technical environment on Alcedis Platforms™.

  • Submissions to ethic committees and notifications of authorities
  • Creation of study material and plans for Data Management, Risk-Management, Statistical Analysis or Monitoring
  • Set-up of drug supply, sample management and laboratories
  • Customization of eCRF, choice of plugins and interfaces, set-up to additional data sources via Alcedis Platforms™
  • Site feasibility, identification, contracting, training and initiation

Recruitment

As the recruitment phase is crucial for the course of the study, we make sure that everything is on schedule and sites receive any support needed.

  • Intensive site support and helpdesk
  • Early data reviews after the first patients are included
  • Constant safety monitoring
  • Intensified reporting and communication with the sponsor and other stakeholder

Documentation

Reliable performance throughout the entire study duration - compliant and on time. We deliver wide ranging services to ensure data quality, safety and smooth study and site administration.

  • Continuous data monitoring, coding, reviews and query management
  • AE handling, reconciliations and pharmacovigilance reportings
  • Conducting on-site visits and remote monitoring
  • Investigator remuneration and study budget control
  • Organization of investigator meetings, DSMBs or steering committee meetings
  • Gaining first insights through interim analysis

Analysis & Archiving

After final database closure, we follow up with processing and analyzing the collected data for required study reporting, before the study project is successfully completed in the course of all archiving procedures.

  • Final statistical analysis
  • Preparation of clinical study reports, publications and scientific presentations
  • Archiving of TMF documents and CRF provision for sites

Monitoring Services

We offer comprehensive clinical monitoring services that are tailored to the specific needs of sponsors and their clinical trial projects.

Learn more

"Alcedis has done and developed a lot recently and the EDC system has improved greatly. I highly recommend Alcedis and their EDC System for future studies."

Christian de Vries
Bayer, Principal Data Manager Medical Affairs

"We are collaborating with Alcedis for many years in several indications and as such in some local oncology studies. I believe one of the success factors for Alcedis is their high commitment and the hard work they bring into assigned projects. Besides great expertise in clinical research, another sweet spot is definitely their IT solutions for innovative data capture in clinical studies."

Dr. Lars Mühlenhoff
AstraZeneca, Director Medical Affairs Oncology

"We are collaborating with Alcedis for many years now on local and global observational studies. We particularly appreciate their flexibility to adapt their CRO services and processes to our requirements to deliver highly customized, innovative and user friendly EDC solutions. Work atmosphere is always very professional and collaborative."

Dr. Sabine Friedl
Bayer, Head of TA Oncology & Hematology, Global NIS

"In our collaboration I experience Alcedis as a very cooperative and flexible partner. The internal organisation is very good, which one can see for example in the harmonous and efficient communication between the departments involved. Tasks were always done punctually and in good quality. The project-team was always very open during the creation-process and supported us with good advice, based on the past experience. I am very happy to be working with such an experienced and well-tuned CRO-team. The cooperation is really fun and I would definitively recommend Alcedis!"

Dr. Susanne Oesch
Bayer, Medical Advisor

"We are very enthusiastic about our collaboration with Alcedis. Alcedis was able to implement every request we had, some of them complex and complicated issues, in a quick and efficient manner. After implementation, their support and problem solving skills were impeccable at all times."

Petra Kollien
medac, Med.-wiss. Produktmanagement, Onkologie

"The cooperation between the service-provider Alcedis and our pharmaceutical company AstraZeneca was focused on very diverse and complex tasks as part of clinical trials as well as care research projects from the very beginning on. Employees from both companies collaborate without complication, self-reliantly and result-oriented on a very high, professional level."

Dr. Jörg Wollert
AstraZeneca, Director Value Demonstration

"I have made very good experiences with Alcedis in several global projects over the last years. I recommend their professionalism and hands-on mentality as a full service CRO with excellent eCRF solutions. Working with such a dedicated team was joyful on top and I can fully acknowledge Alcedis as a trusted partner!"

Alexey Medvedchikov
Boehringer Ingelheim, Regional Medical Affairs Operations

"My journey with Alcedis was accompanied with good people with experiences that made the job much enjoyable. Many thanks to all Alcedis team for the hard work and effort to make it happen. You went above and beyond!"

JinKyung Lee
Bayer, Global Project Manager NIS

"We are the market leader of homeopathic products in Germany and thereby dedicate ourselves to collect scientific data on our products. In this context, we are collaborating with Alcedis GmbH on an international clinical trial. From the beginning of our cooperation, we were pleasantly surprised by the high commitment of the Alcedis team. They immediately took ownership of our trial bringing in valuable know-how to turn our ideas into reality. Thanksto their expertise it was possible to tackle technical challenges. Finally, a continously open ear to our special requests illustrates the flexibility of the Alcedis team. It is a pleasure to work with them!"

Dr. Sabine De Jaegere
DHU-Arzneimittel GmbH & Co. KG, Scientific Advisor Clinical Research

"The collaboration with Alcedis works splendidly and we are still very happy to have a competent partner at our side as support for our local studies! And this for many years now already!"

Elke Kreitmair
MSD, Director Medical Operations, Medical Affairs/MRL
"The Alcedis GmbH flexibly adjusts to our needs and thinks very customer-oriented - the feedback of our clinical partners is positive all the way."
Prof. Dr. Ralf Wagner
lophius biosciences, CEO & Chairman of the Board

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